Chronic Low-back PainSAFEBACKNCT05481996
Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain
A study testing App-Based Pain Education and Exercise and Online booklet in people with Chronic Low-back Pain and Telerehabilitation, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain, Telerehabilitation
- What is being tested?
- App-Based Pain Education and Exercise and Online booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Oct 2022to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 60 years
- Chronic low back pain (defined as pain lasting more than 12 weeks)
- Chronic low back pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
- Own a smartphone with internet access and email account
- Police officer (federal, federal highway, civil or military) or military firefighter working in the State of Rio Grande do Sul
Who cannot join
- Present neurological symptoms (nerve root compromise, or sensation deficits)
- Present serious spinal diseases (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases)
- Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes)
- Recent spine surgery (over the last 12 months) or scheduled to undergo surgery in the next six months, or pregnancy
- History of physical therapy treatment for low back pain or physical exercise (strength training for core muscles, Pilates, yoga) current or within the last 3 months
- Retired
- If have any contraindication to exercise:
- We will perform a pre-screening for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version to rule out any contraindication to participate in physical activity
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola Superior de Educação Física
Pelotas, Rio Grande do Sul, 96055-630
About this study
Official title: Effectiveness of an Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain: a Randomized Clinical Trial
The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.
Read the detailed description
Low back pain is the leading cause of year lived with disability worldwide. Workers exposed to physically demanding activities and inappropriate postures, such as those performed by police officers and firefighters, are highly affected by chronic low back pain. Smartphone app-based self-managed interventions have been shown to be an alternative for chronic non-specific low back pain treatment. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic low back pain, especially in police and fire professionals. The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.
- Conditions
- Chronic Low-back Pain, Telerehabilitation
- Being tested
- App-Based Pain Education and Exercise, Online booklet
- Keywords
- low back pain, Telerehabilitation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-Based Pain Education and ExerciseOther
Also called Telerehabilitation
Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a smartphone application created especially for the study that will contain a program of progressive physical exercises with images and descriptions, educational messages and an online booklet for the study subjects, totaling 8 weeks of training and pain education.
Online bookletOther
An online booklet containing information about chronic low back pain and weekly messages about low back pain causes, suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.
| Study group | Role | What they receive |
|---|---|---|
| App-Based Pain Education and Exercise | Experimental | Patients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. Receives: Other: App-Based Pain Education and Exercise |
| Online Booklet | Active comparator | Patients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. Receives: Other: Online booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at post-treatment follow-up
The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.
Measured: Post-treatment follow-up (8 weeks)
Disability at post-treatment follow-up
The primary outcome will be disability measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability.
Measured: Post-treatment follow-up (8 weeks)
Secondary outcomes (12)
Pain intensity at 4 months follow-up
Measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.
Measured: 4 months follow-up
Disability at 4 months follow-up
Measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability.
Measured: 4 months follow-up
Health-Related Quality of Life
Measured with the WHOQOL-Pain, a self-reported questionnaire with 16 questions and classification of 4 facets related to the experience of chronic physical pain.
Measured: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Self-efficacy
Measured with Pain Self-Efficacy Questionnaire, a questionnaire with 22 questions classified in three domains, with a score of each domain ranging from 10 to 100. A total score close to 300 indicates a greater sense of self-efficacy.
Measured: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Depression, Anxiety and Stress
Measured by the Depression Anxiety Stress Scale, a self-reported scale with 21 questions, 7 for depression, 7 for anxiety and 7 for stress. Each question ranges from 0 to 3 according to the patient's response. Scores near 21 indicate the worst results.
Measured: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Sleep quality
Measured by the Pittsburgh Sleep Quality Index, a self-reported scale with 19 questions, that assess seven components of sleep. Each question ranges from 0 to 3 according to the patient's response. Scores near 21 indicate worse sleep quality.
Measured: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Work ability
Measured by a single-item question: Are you working at a physically less demanding job now because of your back and/or leg pain?
Measured: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Isometric muscular endurance of the trunk extensor
Measured by modified Biering-Sorensen test.
Measured: The outcome will be evaluated after the treatment period (8 weeks).
Isometric muscular endurance of the trunk flexors
Measured by a test that consists of remaining in isometry as long as possible.
Measured: The outcome will be evaluated after the treatment period (8 weeks).
Maximum isometric strength of the trunk extensor and flexor muscles
Measured by a load cell.
Measured: The outcome will be evaluated after the treatment period (8 weeks).
Muscular activation of flexor and extensor muscles
Measured using the surface electromyography technique. The neuromuscular activation of flexor (rectus abdominis) and extensor (spinal erector) muscles will be measured.
Measured: The outcome will be evaluated after the treatment period (8 weeks).
Adverse Effects
Measured by recording the number of adverse events during the intervention period.
Measured: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start10 Oct 2022
- Primary completion20 Jun 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Intervention group will perform the 8-week treatment with access to 8 pain education messages (1 message/week) and 8 weeks of an exercise program prescribed for people with chronic low back pain, and the control group will receive information on chronic low back pain for one booklet and access to 8 pain education messages (1 message/week). Randomized through software, so that the subject enters his/her login and password and is directed to one of the study groups, with a blind evaluator without access to randomization information throughout the study and follow-up of the outcome measures for 4 months after randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristine Lima Alberton, Federal University of Pelotas
- Investigators
- Cristine Alberton, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481996
- Sponsor's protocol ID
- 58715422.3.0000.5313
- Acronym
- SAFEBACK
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marins EF, Caputo EL, Kruger VL, Junior DM, Scaglioni FG, Del Vecchio FB, Primo TT, Alberton CL. Effectiveness of m-health-based core strengthening exercise and health education for public safety workers with chronic non-specific low back pain: study protocol for a superiority randomized controlled trial (SAFEBACK). Trials. 2023 Dec 1;24(1):780. doi: 10.1186/s13063-023-07833-9.
PubMed 38041180
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05481996
- Acronym / sponsor ID
- SAFEBACK / 58715422.3.0000.5313
- Conditions
- Chronic Low-back Pain, Telerehabilitation
- Keywords
- low back pain, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.
Detailed description
Low back pain is the leading cause of year lived with disability worldwide. Workers exposed to physically demanding activities and inappropriate postures, such as those performed by police officers and firefighters, are highly affected by chronic low back pain. Smartphone app-based self-managed interventions have been shown to be an alternative for chronic non-specific low back pain treatment. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic low back pain, especially in police and fire professionals. The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Intervention group will perform the 8-week treatment with access to 8 pain education messages (1 message/week) and 8 weeks of an exercise program prescribed for people with chronic low back pain, and the control group will receive information on chronic low back pain for one booklet and access to 8 pain education messages (1 message/week). Randomized through software, so that the subject enters his/her login and password and is directed to one of the study groups, with a blind evaluator without access to randomization information throughout the study and follow-up of the outcome measures for 4 months after randomization.
| Arm | Type | Receives |
|---|---|---|
| App-Based Pain Education and Exercise | Experimental | Other: App-Based Pain Education and ExercisePatients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. |
| Online Booklet | Active comparator | Other: Online bookletPatients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 and 60 years
- Chronic low back pain (defined as pain lasting more than 12 weeks)
- Chronic low back pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
- Own a smartphone with internet access and email account
- Police officer (federal, federal highway, civil or military) or military firefighter working in the State of Rio Grande do Sul
Key exclusion criteria (8 listed)
- Present neurological symptoms (nerve root compromise, or sensation deficits)
- Present serious spinal diseases (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases)
- Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes)
- Recent spine surgery (over the last 12 months) or scheduled to undergo surgery in the next six months, or pregnancy
- History of physical therapy treatment for low back pain or physical exercise (strength training for core muscles, Pilates, yoga) current or within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-Based Pain Education and ExerciseAlso: TelerehabilitationTelerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a smartphone application created especially for the study that will contain a program of progressive physical exercises with images and descriptions, educational messages and an online booklet for the study subjects, totaling 8 weeks of training and pain education. | Other | App-Based Pain Education and Exercise |
| Online bookletAn online booklet containing information about chronic low back pain and weekly messages about low back pain causes, suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises. | Other | Online Booklet |
Primary outcome
Pain Intensity at post-treatment follow-up
Time frame: Post-treatment follow-up (8 weeks)
The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.
Disability at post-treatment follow-up
Time frame: Post-treatment follow-up (8 weeks)
The primary outcome will be disability measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability.
12 secondary outcomes
Pain intensity at 4 months follow-up
Time frame: 4 months follow-up
Disability at 4 months follow-up
Time frame: 4 months follow-up
Health-Related Quality of Life
Time frame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Self-efficacy
Time frame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Depression, Anxiety and Stress
Time frame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Sleep quality
Time frame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Work ability
Time frame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Isometric muscular endurance of the trunk extensor
Time frame: The outcome will be evaluated after the treatment period (8 weeks).
Isometric muscular endurance of the trunk flexors
Time frame: The outcome will be evaluated after the treatment period (8 weeks).
Maximum isometric strength of the trunk extensor and flexor muscles
Time frame: The outcome will be evaluated after the treatment period (8 weeks).
Muscular activation of flexor and extensor muscles
Time frame: The outcome will be evaluated after the treatment period (8 weeks).
Adverse Effects
Time frame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 38041180Marins EF, Caputo EL, Kruger VL, Junior DM, Scaglioni FG, Del Vecchio FB, Primo TT, Alberton CL. Effectiveness of m-health-based core strengthening exercise and health education for public safety workers with chronic non-specific low back pain: study protocol for a superiority randomized controlled trial (SAFEBACK). Trials. 2023 Dec 1;24(1):780. doi: 10.1186/s13063-023-07833-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristine Alberton, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-Based Pain Education and Exercise and Online booklet in people with Chronic Low-back Pain and Telerehabilitation, run by Federal University of Pelotas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity at post-treatment follow-up (time frame: Post-treatment follow-up (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.